DePuy Synthes 12.5mm Reamer Head Recalled for Breakage and Tissue Damage
Synthes (USA) Products LLC is recalling DePuy Synthes 12.5mm Reamer Heads for RIA 2 due to breakage exceeding expected rates, which can cause tissue and bone damage.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly reports adverse tissue reaction, soft tissue damage, and bone damage, which aligns with the rubric criterion for 'significant injury' reports, warranting a score of 4.
Plain-English summary
Synthes (USA) Products LLC is recalling the DePuy Synthes 12.5MM REAMER HEAD FOR RIA 2 STERILE, an orthopedic manual surgical instrument. The recall involves 1,337 units in the United States and 453 units outside the United States. The affected product is identified by Part Code 03.404.021S and UDI 10886982274007.
The recall is being conducted because the reamer head breakage exceeds the expected occurrence rate. This breakage can result in adverse tissue reaction, soft tissue damage, and/or bone damage when recommended surgical techniques are not followed. The agency has classified this as a Class II recall.
The product was distributed nationwide and to foreign countries including the United Arab Emirates, Austria, Australia, Belgium, Switzerland, China, Czech Republic, Germany, Spain, United Kingdom, Ireland, Israel, Italy, and Singapore. Healthcare providers and facilities should stop using the affected reamer heads and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- DePuy Synthes 12.5MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.021S
- Manufacturer
- Synthes (USA) Products LLC
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots UDI: 10886982274007
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 17 recalled by Synthes (USA) Products LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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